Tags: Life Sciences
Belgian Pharma Law Summer Blog Series (Part 3): the recently passed ‘Bill containing various provisions on health’
In our Belgian Pharma Law Summer Blog Series, we examine recent developments in Belgian pharmaceutical law. Whether you are looking for an informative summer read or a concise overview of the latest legal developments to catch up on after the holidays, our series has you covered. Our third and final part examines the ‘Bill containing […]
Belgian Pharma Law Summer Blog Series (Part 2): the new ‘Article 10 guidance’ on pharmaceutical promotion
In our Belgian Pharma Law Summer Blog Series, we examine recent developments in Belgian pharmaceutical law. Whether you are looking for an informative summer read or a concise overview of the latest legal developments to catch up on after the holidays, our series has you covered. Part 2 focuses on the new guidance on the […]
Belgian Pharma Law Summer Blog Series (Part 1): the Act of 30 May 2026 containing various provisions on medicinal and health products
In our Belgian Pharma Law Summer Blog Series, we examine recent developments in Belgian pharmaceutical law. Whether you are looking for an informative summer read or a concise overview of the latest legal developments to catch up on after the holidays, our series has you covered. Part 1 focuses on the Act of 30 May […]
New EU sample retention rules coming up for veterinary medicines repackaged for parallel trade
The Veterinary Medicinal Products Regulation (EU) 2019/6 has applied in the EU since 28 January 2022, replacing Directive 2001/82/EC. The new rules on good manufacturing practice (GMP) will in turn be fleshed out by Commission Implementing Regulation (EU) 2025/2091, which will apply from 16 July 2026. In addition, the European Commission is introducing new GMP requirements concerning the retention of samples for veterinary medicinal products that are repackaged for parallel trade. This blog post briefly examines what these new obligations entail.
Agri-food Law Seminar 2026
We are excited to announce that our annual Agri-food Law Seminar will return to Brussels on 5 June 2026!
EU General Court bars patient association from challenging medicine authorisation refusal
In Case T‑278/25, the EU General Court recently dismissed as inadmissible a challenge brought by a patient advocacy association against the European Commission’s refusal to renew the conditional marketing authorisation for a treatment against Duchenne muscular dystrophy (DMD). The case is significant because it adds to the case law on contesting Commission decisions relating to the marketing of medicinal products. In this blog post, we look at how the Court came to the conclusion that the association lacked standing to litigate and use this as a basis for an informal categorisation of the existing case law.
Despite EU harmonisation, Member States may impose authorisation requirements on pharmacy-prepared medicines, rules EU Court of Justice
Under EU pharmaceutical law, certain medicines fall outside the scope of Directive 2001/83/EC (i.e. the Community code on medicinal products for human use). This includes “magistral formulae” (prepared in a pharmacy for an individual patient on prescription) and “officinal formulae” (prepared in a pharmacy in accordance with a pharmacopoeia and supplied directly to that pharmacy’s […]
EU General Court: technical vaccine data does not have to be disclosed on request
The EU General Court delivered a significant judgment concerning access to documents held by the European Medicines Agency (EMA), this time relating to a conditionally authorised COVID-19 vaccine. This case (T-623/22) serves as an addition to the elaborate case law on the balance between transparency in health matters and the protection of companies’ commercial interests. On this (rare) occasion, the commercial interests of the conditional marketing authorisation (‘MA’) holder prevailed, although an appeal is currently pending (C-38/26 P).
Belgium’s healthcare plans for 2026 – and where pharma fits in
Every year, Belgium’s federal ministers publish their policy notes for discussion in Parliament. They give a high-level snapshot of what each minister plans to focus on in the coming year. For the pharmaceutical industry, the healthcare policy noteis usually the one to watch. Interestingly, the economic policy notealso weighs in on pharma this year. In this blog post, we unpack the key policy signals for the pharmaceutical sector and group them around three main pillars: budget, accessibility, andpricing.
Where food law meets intellectual property: Food IP through last year’s case law
Government decisions can often have a significant impact on companies in the agrifood and life sciences sectors. But what options do you have if you disagree with such a decision? Which steps are available to you, and which route – administrative or judicial – is the most suitable in your case?
Belgian Parliament has adopted urgent 2026 healthcare budget measures: what’s the impact on the pharma industry?
Over the Christmas break, the Belgian Parliament adopted an urgent law with several measures linked to the approved 2026 healthcare budget, with effect from 1 January 2026. The law is intentionally limited to provisions that must enter into force immediately to ensure that the required savings and revenues are available from the start of the […]
EU Reaches Pharma Package Deal: Key Changes at a Glance
On 11 December 2025, following overnight negotiations, the Council and the European Parliament announced a political agreement on the long-awaited Pharma Package (see here). The reform seeks to update the EU’s pharmaceutical rulebook to facilitate access to safe and affordable treatments and bolster the life sciences sector’s competitiveness. While more detailed information is still trickling […]
Silent night, mighty right? The ascent of the variety denomination | Plant Variety Rights X-Mas Special – Part 2
Plant Variety Rights (PVR) quietly shape how new varieties reach our fields, kitchens and shop shelves. As we wrap up the year, it’s the perfect moment to reflect on what’s been cooking in the world of PVR. Building on last year’s insights, this year’s focus is on the increasing importance and enforcement of variety denominations—not […]
Belgian Constitutional Court strikes down pharma industry ‘unavailability contribution’
The Belgian Constitutional Court (“CC”), on 6 November 2025, annulled some provisions of the Law of 18 May 2024 containing various provisions on health and finance, striking down the pharma industry ‘unavailability contribution’. Background Parts of the above Law sought to protect patients from bearing additional costs when reimbursable medicines become unavailable and must be […]
Food Hygiene for Fish: EU General Court Requires Scientific Basis to “Clarify” the Law
Food company Mowi Poland successfully challenged the European Commission’s new hygiene rules governing ‘stiffening’—a specialised fish processing technique—on the grounds that the Commission failed to obtain mandatory scientific consultation. While the Commission defended its approach by characterising the measures as mere “clarification” of existing law and citing industry guidelines as support, the EU General Court […]
Combination therapies in Belgium: how to collaborate without breaching competition law
As the landscape of modern medicine evolves, combination therapies—those that use two or more distinct medicines, often from different companies—are becoming increasingly vital, especially in treating complex diseases like cancer. These therapies promise improved clinical outcomes through synergistic mechanisms of action. However, the reimbursement process for such therapies presents significant regulatory and legal challenges, particularly […]
LSS: Challenging Government Decisions: Legal Strategies in Agri-food & Life Sciences
Government decisions can often have a significant impact on companies in the agrifood and life sciences sectors. But what options do you have if you disagree with such a decision? Which steps are available to you, and which route – administrative or judicial – is the most suitable in your case?
Titanium dioxide: General Court strikes down classification as human carcinogen and ECJ now confirms
The European Commission often relies on scientific evidence for its regulatory decisions. But when challenged, how much deference is owed to the regulator’s interpretation of the underlying science?
REACH obligation to register imported chemicals may be assumed by a person other than the buyer
Under the EU’s REACH Regulation 1907/2006, substances must be registered with the European Chemicals Agency before being imported. The duty to register lies with the importer. In practice, the act of ‘importing’ often involves multiples actors, including the seller, the buyer and various intermediaries who move the goods across borders. So, who then should register […]
Two kiwis a day to chase constipation away – European Commission approves fruit health claim
The European Commission has authorised a new food health claim recognising the digestive health benefits of green kiwifruit. The claim—“Consumption of green kiwifruit contributes to normal bowel function by increasing stool frequency”—has recently been added to the Union list of permitted claims under Regulation (EU) No 432/2012, following a five-year authorisation process. Food-related health claims […]
Procurement of medical devices: New measures between the EU and China
Measures imposed by the EU On 30 June 2025, several measures entered into force that were imposed by the European Commission regarding the purchase of medical equipment originating from China. The following two measures apply: Bidders must therefore ensure that goods and services of Chinese origin do not exceed 50% of the total contract value […]
Category Captains beware!: Belgian competition authority fines Category Management of OTC medicines
On 24 April 2025, the Belgian Competition Authority (BCA) announced a landmark decision imposing fines totaling over €11.2 million on three major pharmaceutical companies for their involvement in a long-running anti-competitive arrangement concerning the placement of over-the-counter (OTC) medicines in Belgian pharmacies..
The new Belgian government’s public health policy: 10 key take-aways for pharma policy
The new Belgian federal government has outlined its vision for public health in a policy paper under the slogan “More money for health, more health for our money”. Public health is a high-priority sector with a significant budget, and the policy paper introduces several key measures that will shape the pharmaceutical industry in the coming years. For pharma companies operating in Belgium, these developments bring both new regulatory challenges and strategic opportunities. Here is a focused analysis of ten key changes and their potential impact on the pharma industry.
CJEU’s DocMorris Ruling: where is the line for pharmaceutical advertising?
The intersection of pharmaceutical advertising, consumer protection, and internal market freedoms remains a complex legal battleground within the EU. In Apothekerkammer Nordrhein v. DocMorris NV (C-517/23), the Court of Justice of the European Union (CJEU) revisited the meaning of ‘advertising of medicinal products’, clarifying how far national restrictions on pharmaceutical advertisements can go under EU pharmaceutical law and internal market principles.